Device recall
Z-2091-2019: Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning…
FDA device recall · Class II · Elekta Inc
Key facts
| Recall number (Z-number) | Z-2091-2019 |
|---|---|
| Recall event | 83273 |
| Product | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System |
| Product code | MUJ |
| Recalling firm | Elekta Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K151233 |
| FEI number | 1937649 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database